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FROM THE LIVER MEETING 2014
A combined formula of ABT-450 with ritonavir, ombitasvir, and dasabuvir, given with ribavirin, yielded high rates of sustained viral response at 12 weeks among patients with hepatitis C virus genotype 1 and cirrhosis, according to work presented at the annual meeting of the American Association for the Study of Liver Diseases.
The regimen worked well in a “broad range of subgroups, including patients with evidence of impaired hepatic synthetic function and/or evidence of portal hypertension,” according to the study, led by Dr. Michael W. Fried, professor of medicine and director of the liver center at the University of North Carolina, Chapel Hill.
Investigators analyzed results from 380 patients randomly assigned to the therapy – coformulated ABT-450/r/ombitasvir+dasabuvir with ribavirin – for either 12 weeks or 24 weeks in the phase III TURQUOISE-II trial. They used sustained viral response to treatment at 12 weeks (SVR12) as the primary outcome measure.
Overall, SVR12 rates were 91.8% for patients taking the drug regimen for 12 weeks, and 96.5% for those taking it for 24 weeks. SVR12 rates did not differ substantially by sex, age, body mass index, or HCV RNA levels. SVR rates ranged from 83.3% at 12 weeks to 96.2% at 24 weeks in patients with platelet counts < 90 × 109/L, and from 84% at 12 weeks to 88.9% at 24 weeks in patients with serum albumin < 35 g/L.
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FROM THE LIVER MEETING 2014
A combined formula of ABT-450 with ritonavir, ombitasvir, and dasabuvir, given with ribavirin, yielded high rates of sustained viral response at 12 weeks among patients with hepatitis C virus genotype 1 and cirrhosis, according to work presented at the annual meeting of the American Association for the Study of Liver Diseases.
The regimen worked well in a “broad range of subgroups, including patients with evidence of impaired hepatic synthetic function and/or evidence of portal hypertension,” according to the study, led by Dr. Michael W. Fried, professor of medicine and director of the liver center at the University of North Carolina, Chapel Hill.
Investigators analyzed results from 380 patients randomly assigned to the therapy – coformulated ABT-450/r/ombitasvir+dasabuvir with ribavirin – for either 12 weeks or 24 weeks in the phase III TURQUOISE-II trial. They used sustained viral response to treatment at 12 weeks (SVR12) as the primary outcome measure.
Overall, SVR12 rates were 91.8% for patients taking the drug regimen for 12 weeks, and 96.5% for those taking it for 24 weeks. SVR12 rates did not differ substantially by sex, age, body mass index, or HCV RNA levels. SVR rates ranged from 83.3% at 12 weeks to 96.2% at 24 weeks in patients with platelet counts < 90 × 109/L, and from 84% at 12 weeks to 88.9% at 24 weeks in patients with serum albumin < 35 g/L.
[email protected]
FROM THE LIVER MEETING 2014
A combined formula of ABT-450 with ritonavir, ombitasvir, and dasabuvir, given with ribavirin, yielded high rates of sustained viral response at 12 weeks among patients with hepatitis C virus genotype 1 and cirrhosis, according to work presented at the annual meeting of the American Association for the Study of Liver Diseases.
The regimen worked well in a “broad range of subgroups, including patients with evidence of impaired hepatic synthetic function and/or evidence of portal hypertension,” according to the study, led by Dr. Michael W. Fried, professor of medicine and director of the liver center at the University of North Carolina, Chapel Hill.
Investigators analyzed results from 380 patients randomly assigned to the therapy – coformulated ABT-450/r/ombitasvir+dasabuvir with ribavirin – for either 12 weeks or 24 weeks in the phase III TURQUOISE-II trial. They used sustained viral response to treatment at 12 weeks (SVR12) as the primary outcome measure.
Overall, SVR12 rates were 91.8% for patients taking the drug regimen for 12 weeks, and 96.5% for those taking it for 24 weeks. SVR12 rates did not differ substantially by sex, age, body mass index, or HCV RNA levels. SVR rates ranged from 83.3% at 12 weeks to 96.2% at 24 weeks in patients with platelet counts < 90 × 109/L, and from 84% at 12 weeks to 88.9% at 24 weeks in patients with serum albumin < 35 g/L.
[email protected]
Key clinical point: A formulation of ABT-450 with ritonavir, ombitasvir, and dasabuvir, given with ribavirin, can yield sustained viral response to treatment among HCV genotype 1–infected patients with cirrhosis.
Major finding: The therapy achieved SVR12 rates of 91.8% and 95.9% for patients treated with the drug regimen for 12 and 24 weeks, respectively.
Data source: The phase III TURQUOISE-II trial.
Disclosures: The trial was sponsored by AbbVie, manufacturer of ABT-450. Dr. Fried has ties with AbbVie and other drug companies. Coauthors disclosed ties with various drug companies; two coauthors are employees of AbbVie.